MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14; BIOLOX CERAMIC FEMORAL HEAD PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 28mm i.D.40mm o.D.Size d bearing; item# 110031010; lot# 65560546.Femoral stem cementless collarless standard offset 12/14 taper size 2; item# 574101020; lot# 3188916.Competitor 50mm shell size liner uncemented 2-hole; item# 0100000705; lot# 7735258.Competitor 40mm bearing size liner size d; item# 110024462; lot# 66175899.G2: foreign ¿ belgium.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately one day post-implantation, the patient underwent a hip revision due to a fall and hip dislocation.During surgery, the surgeon found an intra-prosthetic dislocation of the head out of the bearing.The head and bearing were revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; d10 g3; h2; h3; h6 corrected:d10 d10: 28mm i.D.40mm o.D.Size d bearing; item# 110031010; lot# 65560546 femoral stem cementless collarless standard offset 12/14 taper size 2; item# 574101020; lot# 3188916 g7 bonemaster ltd acet shl 50d; item# 010000702 ; lot# 7735958 g7 dual mobility liner 40mm d; item# 110024462 ; lot# 66175899 the reported product was returned to the product surveillance team for examination.The ceramic femoral head, in particular the articulating surface, is covered in metal smearing, likely occurring after the reported event of dislocation/disassociation and/or during revision surgery.Additionally, metal smearing can be identified within the taper connection.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.One undated radiograph of the left hip was provided and reviewed by a radiologist with the following assessment: left total hip arthroplasty with superior and likely posterior dislocation of the femoral component.Surgical skin staples suggest recent placement.Surgical drain and soft tissue air also consistent with recent surgery.No component issues otherwise seen.Based on the available information, the reported event can be confirmed.As per reported event, the patient became ill and fell, leading to a dislocation of the prosthesis.Based on this, it can be assumed that the fall event caused or contributed to the reported event of dislocation.However, as no additional medical records were provided, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that approximately one day post-implantation, the patient underwent a hip revision due to pain that cause a fall and hip dislocation.During surgery, the surgeon found an intra-prosthetic dislocation of the head out of the bearing.The head and bearing were revised.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14
• Common Device Name: BIOLOX CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19691718
• Report Number: 0009613350-2024-00282
• Device Sequence Number: 17912579
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: (01)00889024430297(17)340404(10)3201984
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877502802
• Device Lot Number: 3201984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 12/05/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/19/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown